NCT00185055

Brief Summary

To assess the effects of 3 blood pressure drugs, called angiotensin receptor blockers, on the blood pressure control systems in healthy subjects.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_4 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 16, 2005

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

September 15, 2005

Conditions

Healthy

Keywords

olmesartanvalsartanirbesartanrenin-angiotensin-aldosterone system

Outcome Measures

Primary Outcomes (1)

  • To characterize the plasma renin activity (PRA) and urinary aldosterone response patterns to single doses of olmesartan medoxomil, irbesartan, and valsartan compared to placebo in normal volunteers.

Interventions

Olmesartan medoxomilDRUG
IrbesartanDRUG
ValsartanDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between the ages of 18 to 65
  • In good health

You may not qualify if:

  • Any serious health problems
  • Positive test for HIV, Hepatitis B and C
  • History of drug and alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Olmesartan MedoxomilIrbesartanValsartan

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsPolycyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

November 1, 2004

Study Completion

February 1, 2005

Last Updated

September 16, 2005

Record last verified: 2005-09